Condition category
Nutritional, Metabolic, Endocrine
Date applied
15/09/2017
Date assigned
21/09/2017
Last edited
21/09/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Diabetes is a lifelong condition where the amount of sugar in the blood is too high. The aim of this study is to test the performance of the masked FreeStyle Libre Flash Glucose Monitoring System with and without a potential In-Reader correction, a device designed for people with diabetes to monitor their blood sugar.

Who can participate?
Patients aged 18 and over with type 1 or 2 diabetes

What does the study involve?
Participants wear two masked (blinded) sensors for up to 14 days and take at least four fingerstick blood sugar readings per day whilst wearing the sensors. Participants attend up to six visits at the clinical study site, three of the visits consist of up to 8 hours blood sampling at regular intervals.

What are the possible benefits and risks of participating?
There may be no direct benefit to the participant. The only risks of participating in this study are associated with blood sample collection. These are small but could include pain, bruising, local infection and fainting.

Where is the study run from?
BioKinetic Europe (UK)

When is the study starting and how long is it expected to run for?
September 2017 to December 2017

Who is funding the study?
Abbott Diabetes Care Ltd (UK)

Who is the main contact?
Dr Pamela Reid

Trial website

Contact information

Type

Public

Primary contact

Dr Pamela Reid

ORCID ID

Contact details

Range Road
Witney
OX29 0YL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ADC-UK-PMS-17031

Study information

Scientific title

Effectiveness of a potential in-reader correction for FreeStyle Libre flash sensor glucose data

Acronym

Study hypothesis

Assess the accuracy of the FreeStyle Libre Flash Glucose Monitoring System measured using percentage of readings that are within ±20% of the YSI reference value for glucose levels ≥ 80 mg/dL (4.4 mmol/L) and within ±20 mg/dL (1.1 mmol/L) for YSI glucose levels <80 mg/dL(4.4 mmol/L), with and without a potential In-Reader correction.

Ethics approval

Health and Social Care Research Ethics Committee A (HSC REC A), 11/09/2017, REC ref: 17/NI/0156; IRAS Project ID: 230816

Study design

Prospective single-arm trial

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Diabetes mellitus

Intervention

Participants will wear two masked sensors for a period of up to 14 days. They will be requested to obtain at least four fingerstick readings per day whilst wearing the sensors (using the built-in test strip port in one of the study readers). Participants will have three in-clinic visits; each in-clinic visit will consist of eight hours of reference sampling at 15 minute intervals, from an IV port.

Intervention type

Device

Phase

Drug names

Primary outcome measures

The point accuracy of the FreeStyle Libre Flash Glucose Monitoring System, measured using percentage of readings that are within ±20% of the YSI reference value for glucose levels ≥ 80 mg/dL (4.4 mmol/L) and within ±20 mg/dL (1.1 mmol/L) for YSI glucose levels <80 mg/dL(4.4 mmol/L), with and without a potential In-Reader correction. Measured on days 1, 2, 5, 7, 11 and 14 of sensor wear.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

15/09/2017

Overall trial end date

31/12/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 years or over
2. Type 1 or type 2 diabetes requiring insulin therapy for at least 6 months prior to enrolment
3. Participant reports self-testing their blood glucose levels at least twice per day
4. Suitable venous access for study participation

Participant type

Other

Age group

Adult

Gender

Both

Target number of participants

Approximately 27 participants will be recruited

Participant exclusion criteria

1. Have a known allergy to medical grade adhesive
2. Be pregnant or planning to become pregnant within the study duration
3. Have skin abnormality at the application sites
4. Have a pacemaker or any other neurostimulators
5. Have concomitant medical condition which in the investigator’s opinion could interfere with the study or present a risk to the safety or welfare of the participant or study staff
6. Have anaemia
7. Currently participating in another clinical study
8. Participant is unsuitable for participation due to any other cause as determined by the Investigator

Recruitment start date

18/09/2017

Recruitment end date

30/11/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

BioKinetic Europe
BT2 7BA

Sponsor information

Organisation

Abbott Diabetes Care Ltd

Sponsor details

Range Road
Witney
OX29 0YL
United Kingdom

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Abbott Diabetes Care

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Results and Publications

Publication and dissemination plan

Planned publication in a peer reviewed journal or conference presentation. Publication date January 2019.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from ADC_Witney_ClinicalAffairs@abbott.com.

Intention to publish date

01/01/2019

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes